Members of racial and ethnic groups that are disproportionately affected by diabetes and at higher risk of developing diabetic macular edema (DME) responded well to treatment with faricimab (Vabysmo; Genentech), according to ELEVATUM study data presented during the 2024 American Academy of Ophthalmology (AAO) meeting in Chicago.

ELEVATUM is a phase 4 study designed to investigate treatment response in underrepresented treatment-naïve patients with DME. The study design was similar to the YOSEMITE and RHINE phase 3 trials, which assessed the efficacy, safety, and durability of faricimab compared to aflibercept in DME patients. The ELEVATUM study population included 124 adult patients who self-identified as Black/African American, Hispanic/Latino American, or Native American/Pacific Islander. Participants received 6 mg faricimab intravitreal injections every 4 weeks (Q4W) up to week 20, followed by 6 mg injections every 8 weeks (Q8W) up to week 52. The primary outcome was change in best-corrected visual acuity (BCVA) from baseline at week 56, as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

“The results were amazing,” said Jeremiah Brown, MD, who presented top-line data from ELEVATUM during the late-breaking developments session of Friday’s Retina Subspecialty Day program. “There were some intergroup differences — for example, the Hispanic group had more edema, so thicker retinas, and their vision was slightly worse at baseline, but they were actually the best responders. Their number of ETDRS letters gained was greater than the average person in YOSEMITE and RHINE, gaining about 14 letters, whereas in YOSEMITE and RHINE the number was about 12 letters gained at the end of 1 year.” The Hispanic/Latino group also showed the best performance in retinal drying at 3 months, he said.

Members of the other groups studied had similar responses to the average patient in YOSEMITE and RHINE, said Dr. Brown, with the Black/African American group gaining 11.3 EDTRS letters. Investigators felt the Native American/Pacific Islander group was too small to make meaningful conclusions from the data, he said. There were no safety concerns, he said: 3 cases of mild iritis were treated with drops, no cases of vasculitis, and 1 case of endophthalmitis that resolved with treatment.

Many ELEVATUM participants have chosen to participate in a 1-year extension study, so that additional information can be gathered. “In the second year it’s a personalized treatment interval,” said Dr. Brown. “Depending on how they’re doing, we can extend them out from every other month to 3 or 4 months.” In some cases, the treatment interval could be extended up to 24 weeks, he said.

Although these top-line data are exciting, Dr. Brown anticipates additional findings as the study data is analyzed. “We did frequent aqueous humor taps [during the study], so we’re looking at cytokines, measuring the VEGF levels at certain points, measuring the Ang-2 levels,” he said. “We’re looking into polymorphisms of different genes to see the response. We’ve also got information related to socioeconomic status and body mass index, because all these things are playing a part. Much more data will come from ELEVATUM over the next few years.” RP